“undetected, unsuspected, and unknown”: should we anticipate problems for scientific innovation ...

40 Pages·2013·0.2 MB·English

“UNDETECTED, UNSUSPECTED, AND
UNKNOWN”: SHOULD WE ANTICIPATE
PROBLEMS FOR SCIENTIFIC INNOVATION
FOLLOWING SCHERING CORP. V. GENEVA
PHARMACEUTICALS?
Jeffrey Coleman*

Once termed the “metaphysics” of patent law, the doctrine of inherent
anticipation has befuddled courts and practitioners alike for decades.
Inherent anticipation refers to the notion that a previously published
reference can disclose each and every limitation of a later-patented
invention without expressly delineating those limitations. These
(un)disclosed limitations are necessarily present, or inherent, within the
previously published reference. When a previously published reference
discloses a later-claimed invention expressly or inherently, the patent
covering the later-claimed invention is invalid because the invention lacks
novelty. Thus, the doctrine of inherent anticipation allows invalidation of a
patent in whole or in part upon a showing that a prior reference contained
a patentee’s later-disclosed invention, even if the earlier reference did not
expressly disclose what the patentee claimed as his invention.
Courts, including the Federal Circuit, have grappled with whether a
person having ordinary skill in the relevant art must recognize inherent
features in the prior art reference for the doctrine of inherent anticipation
to apply. The resulting intracircuit split in Federal Circuit case law
fostered two competing schools of thought on this issue. The Federal
Circuit eventually held that recognition of inherent features is not required.
Commentators, however, have called upon the court to revisit the doctrine
due to its potential chilling effects on innovation. This Note suggests that
the Federal Circuit should reexamine the doctrine, paying particular
attention to considerations of whether or not a person having ordinary skill
in the art was capable of identifying inherent features in the asserted prior
art reference. Clarification, or even outright reformation, of the inherent
anticipation doctrine grows more imperative as our technological
capabilities quickly outpace our legal rules.

* J.D. Candidate, 2014, Fordham University School of Law; Ph.D., 2010, Pennsylvania
State University; B.S., 2003, Ursinus College. I would like to thank Inna Burshteyn for her
love and unconditional support. I would also like to thank Professor John Richards for
teaching me patent law and for helpful discussions.
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166 FORDHAM LAW REVIEW [Vol. 82
TABLE OF CONTENTS
INTRODUCTION .......................................................................................... 166 
I. A PATENT LAW PRIMER ........................................................................ 170 
A. Anticipation Generally .............................................................. 172 
B. From Unwitting Result to Necessary Consequence:
The Evolution of the Inherent Anticipation Doctrine .............. 175 
II. A PERSON HAVING ORDINARY SKILL IN THE ART MUST
(SOMETIMES) RECOGNIZE THE INHERENT FEATURE: AN
INTRACIRCUIT SPLIT ...................................................................... 178 
A. PHOSITA Recognition Required .............................................. 179 
B. PHOSITA Recognition Not Required ....................................... 182 
C. Settling the Debate, for Now: Schering Corp. v. Geneva
Pharmaceuticals, Inc. .............................................................. 185 
1. The Procedural History ...................................................... 186 
2. The Appeal to the Federal Circuit ...................................... 187 
3. Denial of En Banc Review ................................................. 189 
4. Formal Acceptance of Schering Corp.: The Case of
SmithKline Beecham Corp. v. Apotex Corp. .................... 191 
D. Predictions for the Future of Metabolite Research .................. 195 
III. TECHNOLOGICAL ADVANCEMENT IN THE TIME OF SCHERING
CORP.: REEXAMINING THE DOCTRINE IN LIGHT OF OUR
RAPIDLY EXPANDING BASE OF SCIENTIFIC KNOWLEDGE ............. 196 
A. Proposed Changes to the Doctrine ........................................... 196 
B. Towards a New “Capability” Standard for Inherent
Anticipation Analyses in Patent Cases .................................... 198 
CONCLUSION ............................................................................................. 203 
INTRODUCTION
Humans lit fires for thousands of years before realizing that oxygen is
necessary to create and maintain a flame. The first person to discover the
necessity of oxygen certainly could not have obtained a valid patent claim
for “a method of making a fire by lighting a flame in the presence of
oxygen.” Even if prior art on lighting fires did not disclose the
importance of oxygen and one of ordinary skill in the art did not know
about the importance of oxygen, understanding this law of nature would
not give the discoverer a right to exclude others from practicing the prior
art of making fires.1
The doctrine of inherent anticipation has been described as “a puzzle that
runs throughout patent law,”2 a “troublesome area of U.S. patent law,”3 and

1. EMI Grp. N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1351 (Fed.
Cir. 2001).
2. Dan L. Burk & Mark A. Lemley, Inherency, 47 WM. & MARY L. REV. 371, 372
(2005).
3. Janice M. Mueller & Donald S. Chisum, Enabling Patent Law’s Inherent
Anticipation Doctrine, 45 HOUS. L. REV. 1101, 1102 (2008).
2013] PROBLEMS AFTER SCHERING CORP.? 167
a “doctrinal morass.”4 The cases forming the underlying basis for the
doctrine of inherent anticipation are confusing, at best, and the resulting
opinions invoking the doctrine are confused, at worst.5
At its core, the doctrine of inherent anticipation functions to preclude
patent protection for new inventions when a previously published reference
discloses “each and every limitation”6 of the invention sought to be
patented.7 U.S. patent laws prescribe that only new inventions may be
patented.8 Obviously, an invention is not new (i.e., novel) when it already
exists, and is therefore ineligible for patent protection.9 Similarly, an
invention is not patentable if it has been expressly described in the prior art
(such as in previously filed specifications in patent applications, journal
articles, or other printed publications).10 However, “[t]echnologies may
have qualities that are unappreciated or unidentified in a patent description,
but which are nonetheless present. The law refers to these unknown
attributes as ‘inherent’ in the product or process.”11 The doctrine of
inherency allows for invalidation of a patent, in whole or in part, when a
prior art reference does not expressly disclose each and every limitation of
the claimed invention.12 A patent is not novel (or patentable) for inherency
when a single prior art reference inherently describes a missing feature of
the claimed invention, so long as the missing feature is a deliberate or a

4. Id. at 1103.
5. See Burk & Lemley, supra note 2, at 373 (“The cases appear to flatly contradict each
other, are often accompanied by dissents, and in the last three years alone have triggered one
abortive en banc rehearing and strong calls for a second.” (citation omitted)).
6. See McClain v. Ortmayer, 141 U.S. 419, 424 (1891) (“[T]he object of the patent law
in requiring the patentee to particularly point out and distinctly claim the part, improvement,
or combination which he claims as his invention or discovery, is not only to secure to him all
to which he is entitled, but to apprise the public of what is still open to them.” (internal
quotation marks omitted)).
7. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003), reh’g
denied, 348 F.3d 992 (Fed. Cir. 2003) (en banc).
8. See 35 U.S.C. § 102 (2006). Further conditions for patentability are outlined in Title
35 of the U.S. Code. Briefly, an invention is eligible for patent protection when it is new,
useful, nonobvious, and directed at statutorily acceptable subject matter. See id. §§ 101–03.
The first paragraph of section 112 further demands that patent applicants set forth a written
description sufficient to prove that they possessed the claimed invention at the time of the
application filing, this description must be enough to enable one skilled in the art to make
and use the invention. See id. § 112, para. 1; see also Ariad Pharms. Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1340 (Fed. Cir. 2010) (en banc) (holding that the first paragraph of § 112
contains a written description requirement separate from enablement). Finally, the patent
application must conclude with claims particularly delineating the bounds of the invention.
See 35 U.S.C. § 112, para. 2.
9. See 35 U.S.C § 102. An invention that is determined not to be novel is said to be
“anticipated.” See infra Part I.A.
10. See 35 U.S.C. § 102. Specifically, section 102(b) states, “A person shall be entitled
to a patent unless . . . the invention was patented or described in a printed publication in this
or a foreign country or in public use or on sale in this country, more than one year prior to
the date of the application for patent.” Essentially, the prior art, or the current state of the
art, sets forth the technological background against which the novelty and nonobviousness of
an invention are examined. See C. Douglas Thomas, Secret Prior Art—Get Your Priorities
Straight!, 9 HARV. J.L. & TECH. 147, 148 (1996).
11. Burk & Lemley, supra note 2, at 372.
12. See Schering Corp., 339 F.3d at 1377.
168 FORDHAM LAW REVIEW [Vol. 82
necessary consequence of what was intended.13 The Federal Circuit has
explained that the doctrine of inherent anticipation requires certainty of
result.14 If the missing feature of the invention is determined to be present
in a prior art reference as a result of an accident, the doctrine of inherent
anticipation is not invoked and the patent covering the invention is not
invalid for inherent anticipation.15
For decades, the case law invoking the doctrine suffered from conflicting
opinions on one particular issue: must a person having ordinary skill in the
art (commonly referred to as “PHOSITA”)16 recognize the existence of the
missing (inherent) feature?17 Some cases explained that a PHOSITA must
recognize the inherent feature before the doctrine may be used to defeat a
patent or some of its claims;18 others held the exact opposite, explaining
that inherent anticipation precludes patentability so long as the inherent
feature is an inevitable consequence of practicing the prior art, whether or
not PHOSITA recognizes the inherent feature.19 In its seminal—and
controversial—2003 decision, Schering Corp. v. Geneva Pharmaceuticals,
Inc.,20 the Federal Circuit explained that the doctrine of inherent
anticipation does not require recognition of the inherent feature by a
PHOSITA.21
In Schering Corp., the Federal Circuit invalidated a patent claim to a
metabolite22 as inherently anticipated in light of the prior art, in this case a
patent for the parent drug.23 The court explained that the patent for the
parent drug precluded patentability of all of its future metabolites, presently
known or unknown, since all metabolites would necessarily be formed
when an individual ingests the parent drug.24 The Schering Corp. decision

13. See 1 DONALD S. CHISUM, CHISUM ON PATENTS, § 3.03[2][c] (2013) (citing Glaxo
Inc. v. Novopharm Ltd., 830 F. Supp. 871, 877 (E.D.N.C. 1993), aff’d, 52 F.3d 1043 (Fed.
Cir. 1995), cert. denied, 516 U.S. 988 (1995) (finding that a method set forth an example in
one patent did not inherently anticipate claims to a variant form of a compound claimed in a
second patent because the “proper practice” of the example sometimes resulted in the
claimed form and sometimes resulted in another form)).
14. See Schering Corp., 339 F.3d at 1377 (“[A] prior art reference may anticipate
without disclosing a feature of the claimed invention if that missing characteristic is
necessarily present, or inherent, in the single anticipating reference.” (emphasis added)
(citing Cont’l Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991))).
15. See Tilghman v. Proctor, 102 U.S. 707, 711–12 (1880).
16. For a more detailed description of the hypothetical person having ordinary skill in
the art (PHOSITA), see infra Part I.
17. See infra Part II.
18. See infra Part II.A.
19. See infra Part II.B.
20. 339 F.3d 1373 (Fed. Cir. 2003).
21. See id. at 1377 (“At the outset, this court rejects the contention that inherent
anticipation requires recognition in the prior art.”).
22. See id. at 1375 (“A metabolite is the compound formed in the patient’s body upon
ingestion of a pharmaceutical. The ingested pharmaceutical undergoes a chemical
conversion in the digestion process to form a new metabolite compound.”).
23. See id. at 1380.
24. See id. (“[T]he record shows that a patient ingesting [the parent drug] would
necessarily metabolize that compound to [a metabolite]. That later act would thus [be an act
2013] PROBLEMS AFTER SCHERING CORP.? 169
diverged from earlier precedent, however, in its holding vis-à-vis
metabolites: all future metabolites of a patented parent drug—whether or
not they are recognized by a PHOSITA at the time the parent drug is
patented—are inherently anticipated25 by the parent drug and are ineligible
for patent protection.26
Several commentators believe that the Schering Corp. decision represents
a carefully considered balancing act by a Federal Circuit attempting to
preserve the goals of the patent system27—namely, to foster innovation by
providing inventors with an exclusive time-limited monopoly to make their
invention on the one hand, and ensuring that the public receives the benefit
of the invention via full disclosure on the other.28 The Schering Corp.
decision may be explained in light of these public policy goals; perhaps the
court was concerned with what it perceived to be patent “evergreening.”29

of patent infringement]. Thus, a prior art reference showing administration of [the parent
drug] to a patient anticipates claims [to the metabolite].”).
25. Essentially, they are not “novel,” and fail the novelty requirement for patentability
under 35 U.S.C. § 102 (2006).
26. See Schering Corp., 339 F.3d at 1380–81.
27. See Cynthia Chen, Schering Corp. v. Geneva Pharmaceuticals, Inc.: Clarification of
the Inherent Anticipation Doctrine and Its Implications, 20 BERKELEY TECH. L.J. 95, 96
(2005) (“The Schering decision represents an effort by the Federal Circuit to balance two
conflicting goals of the patent system: to stimulate inventive efforts by giving inventors
exclusive rights for a limited period and to allow the public at large to derive benefits from
the advances in technology.”); Alfredo De La Rosa, A Hard Pill to Swallow: Does Schering
v. Geneva Endanger Innovation Within the Pharmaceutical Industry?, 8 COLUM. SCI. &
TECH. L. REV. 37, 87 (2007) (“Schering attempted to prevent generic drug manufacturers
from practicing the . . . patent, even after it had entered the public domain. The Federal
Circuit was understandably troubled by this notion.”); Mueller & Chisum, supra note 3, at
1163 (“In cases such as Schering, the Federal Circuit has wielded the doctrine of anticipation
by inherency as a rather blunt instrument to combat perceived patent evergreening.”).
28. See Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 63–64 (1998) (citing Seymour v.
Osborne, 78 U.S. (11 Wall.) 516, 533–34 (1870)). In Seymour, the Supreme Court
explained:
Letters patent are . . . public franchises granted to the inventors of new and useful
improvements for the purpose of securing to them, as such inventors, for the
limited term therein mentioned, the exclusive right and liberty to make and use and
vend to others to be used their own inventions, as tending to promote the progress
of science and the useful arts, and as matter of compensation to the inventors for
their labor, toil, and expense in making the inventions, and reducing the same to
practice for the public benefit, as contemplated by the Constitution and sanctioned
by the laws of Congress.
78 U.S. (11 Wall.) at 533–34.
29. Patent evergreening is not a formal patent law concept, but rather a strategy by
which a patentee obtains, or attempts to obtain, multiple patents that cover different aspects
of the same invention in an effort to extend the term of the patent and the exclusivity
privileges that come with it. See Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1378
n.6 (Fed. Cir. 2002) (noting that new drug application (NDA) holders may evergreen their
patents “by filing a series of applications for different patents covering the same basic
drug”); see also Terry G. Mahn, Patenting Drug Products: Anticipating Hatch-Waxman
Issues During the Claims Drafting Process, 54 FOOD & DRUG L.J. 245, 250 (1999)
(explaining that by filing and refiling “improvement” patents for the same basic drug—such
as disectable tablets, special coatings, new formulations, crystalline forms of the same drug,
and variations on drug delivery technologies—companies may essentially “evergreen their
170 FORDHAM LAW REVIEW [Vol. 82
Although the effect the opinion will have on scientific innovation is
debatable,30 the rule promulgated under Schering Corp. has effectively
settled the argument for the time being about whether a PHOSITA must
recognize the inherent feature, unless and until the Supreme Court weighs
in.
In the Schering Corp. opinion, the Federal Circuit provided some
guidance to future patent drafters about how to circumvent the inherent
anticipation doctrine with respect to metabolites.31 In light of the rapid
advancement of the study of metabolites, and an ever-expanding base of
scientific knowledge in general, however, it behooves the Federal Circuit to
reexamine the inherent anticipation doctrine. This Note focuses on the
evolution and application of the inherent anticipation doctrine in the case
law.
Part I of this Note begins by providing a brief introduction to U.S. patent
law. Specifically, it focuses on the statutory provisions regarding novelty
and anticipation. It also outlines the evolution of the inherent anticipation
doctrine from early U.S. Supreme Court jurisprudence.
Part II examines the intracircuit split that developed within the Federal
Circuit as the court struggled to determine whether PHOSITA recognition
of the inherent feature was necessary for a finding of inherent anticipation.
It then describes the Federal Circuit’s seminal decision in Schering Corp.
and predicts the future of metabolite research in the wake of the
controversial rule that PHOSITA recognition is dispensable in an inherent
anticipation analysis.
Finally, Part III examines proposals for changes to the inherent
anticipation doctrine. This Note then argues for a new “capability” standard
that would focus on what a PHOSITA was capable of discovering at the
time the prior art was published. This Note concludes by arguing that much
of the confusion in the inherent anticipation doctrine may be avoided by
simply focusing on what an inventor was capable of identifying at the time
of the prior art.
I. A PATENT LAW PRIMER
Mark Twain famously opined, “I knew that a country without a patent
office and good patent laws was just a crab, and couldn’t travel any way but
sideways or backwards.”32 The U.S. Constitution expressly mandates the
patent system, which in turn provides to inventors a time-limited monopoly
to make and practice their inventions, and to exclude others from doing the

drug patents”). One such evergreening example relevant to this Note could be the attempted
patenting of a derivative of an existing drug.
30. Compare Chen, supra note 27 (arguing that the necessary and inevitable
consequence test promulgated under Schering Corp. will not harm future metabolite
research), with De La Rosa, supra note 27 (arguing that the inherent anticipation doctrine
will endanger pharmaceutical innovation and encourage recourse to trade secrets).
31. See Schering Corp., 339 F.3d at 1381; see also infra Part II.C.
32. MARK TWAIN, A CONNECTICUT YANKEE IN KING ARTHUR’S COURT 72 (Bernard L.
Stein ed., Univ. of Cal. Press 3d ed. 1979) (1889).
2013] PROBLEMS AFTER SCHERING CORP.? 171
same.33 To be eligible for patent protection, however, an invention must
satisfy the basic requirements for patentability;34 specifically, the invention
must be new (i.e., novel), useful, and nonobvious. The requirement that an
invention be novel, prescribed by 35 U.S.C. § 102, is the cornerstone of the
patent system.35 Novelty is defeated, however, when the invention already
exists.36
To examine novelty, courts scrutinize the claimed invention in light of
the “prior art,”37 which represents the entirety of the “preexisting
knowledge and technology already available to the public.”38 The public
policy behind the novelty provision is to promote efficient research—to put
“libraries before laboratories, investigation before investment.”39 A
previously published document asserted against a claimed invention to
defeat its novelty is commonly referred to as a “prior art reference.”40 A
prior art reference defeats novelty when (1) it predates the applicant’s
invention, (2) it discloses each and every limitation41 of the claimed
invention (either expressly or inherently), and (3) it is enabling (the
reference teaches a person having ordinary skill in the art how to make and
use the invention without undue experimentation).42 When a prior art

33. See U.S. CONST. art. 1, § 8, cl. 8 (“The Congress shall have Power . . . To promote
the Progress of Science and useful Arts, by securing for limited Times to Authors and
Inventors the exclusive Right to their respective Writings and Discoveries.”). An applicant
whose invention satisfies the requirements of novelty, nonobviousness, and utility, and who
discloses his invention to the public is granted “the right to exclude others from using,
offering for sale, or selling the invention throughout the United States” for a period of 20
years. 35 U.S.C. § 154 (2006).
34. See id. §§ 101–03.
35. See id. § 102; see also MARTIN J. ADELMAN ET AL., PATENT LAW IN A NUTSHELL 75
(2008) (“Novelty, the most fundamental characteristic of patentability, ensures that an
inventor has truly created something new.”).
36. See ADELMAN ET AL., supra note 35, at 75.
37. See 35 U.S.C. § 102. “Prior art” may refer to any printed publication, issued patent,
or other document asserted against the claimed invention to defeat its novelty.
38. Sean B. Seymore, Rethinking Novelty in Patent Law, 60 DUKE L.J. 919, 922 (2011);
see also Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453 (Fed. Cir. 1984)
(“[T]he real reason for the denial of patent rights . . . is the basic principle (to which there are
minor exceptions) that no patent should be granted which withdraws from the public domain
technology already available to the public.” (citing Graham v. John Deere Co., 383 U.S. 1, 6
(1966))).
39. ADELMAN ET AL., supra note 35, at 75.
40. Seymore, supra note 38, at 922.
41. Claim limitations stake out the limits of the patentee’s property right. See Renishaw
PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248–49 (Fed. Cir. 1998) (“[T]he
claims define the scope of the right to exclude; the claim construction inquiry, therefore,
begins and ends in all cases with the actual words of the claim.”). Thus, claim limitations
are the words of the claim detailing the specific elements of the invention. See ADELMAN ET
AL., supra note 35 at 218–19 (explaining that claims must describe complex subject matter in
terms broad enough to foresee and capture future related technology and narrow, or limited,
enough to distinguish all past related technology).
42. Seymore, supra note 38, at 922–23. The PHOSITA is a legal fiction of patent law,
considered to possess the normal skills and knowledge of a person in the field, without being
a genius. See Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1566 (Fed. Cir. 1987)
(explaining that a PHOSITA is “not unlike the ‘reasonable man’ and other ghosts in the
law”). The PHOSITA is similar to the reasonably prudent person in tort law, and his
172 FORDHAM LAW REVIEW [Vol. 82
reference successfully defeats the novelty of a claimed invention, that
invention is said to be “anticipated.”43 A finding of anticipation thus
renders the invention unpatentable as a result of the technology already
being within the public domain.44 Part I.A first describes anticipation
generally. Part I.B then traces the evolution of the inherent anticipation
doctrine, as it grew out of an earlier doctrine termed “accidental
anticipation.”
A. Anticipation Generally
A famous patent law adage recites, “That which infringes, if later, would
anticipate, if earlier.”45 A patent cannot issue on an invention or
technology already within the public domain; to allow a patentee an
exclusive monopoly over public technology is injurious to society as a
whole and does not incentivize innovation.46 The novelty provision
guarantees to the public the right to make and use that which it already
possesses.47
An invention that is anticipated by the prior art is not novel.48
Anticipation is a pure question of fact.49 Courts assess anticipation using a
two-step analysis: (1) by analyzing the current state of public knowledge as
indicated by the prior art, and (2) by examining each prior art reference
individually to determine if a single reference discloses each and every
limitation of the claimed invention.50 Assessing the novelty of a simple

hypothetical construction can change depending on several factors, such as “(1) the
educational level of the inventor; (2) type of problems encountered in the art; (3) prior art
solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication
of the technology; and (6) educational level of active workers in the field.” Envtl. Designs,
Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
43. See Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987)
(“A claim is anticipated only if each and every element as set forth in the claim is found,
either expressly or inherently described, in a single prior art reference.”).
44. See ADELMAN ET AL., supra note 35, at 75–76.
45. Peters v. Active Mfg. Co., 129 U.S. 530, 537 (1889).
46. See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 148 (1989)
(stating that to allow a patentee a patent on an anticipated invention “would in fact injure the
public by removing existing knowledge from public use”); Graham v. John Deere Co., 383
U.S. 1, 5–6 (1966) (holding that it would be unconstitutional for Congress to authorize the
issuance of patents that would remove existing knowledge from the public domain).
47. See Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453–54 (Fed. Cir.
1984). The Federal Circuit stated:
That is the real meaning of ‘prior art’ in legal theory—it is knowledge that is
available, including what would be obvious from it, at a given time, to a person of
ordinary skill in an art. Society, speaking through Congress and the courts, has said
“thou shalt not take it away.”
Id.
48. See Standard Havens Prods., Inc. v. Gencor Indus., Inc., 953 F.2d 1360, 1367 (Fed.
Cir. 1991) (citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1574 (Fed. Cir.
1985)).
49. See id. (“[A]nticipation is a factual determination.”).
50. See ADELMAN ET AL., supra note 35, at 76. The limitations of the claimed invention
are defined by the claims in the patent application. See id. at 218. The claims are “the fence
around the inventor’s property right,” defining the boundaries of the patentee’s right to
2013] PROBLEMS AFTER SCHERING CORP.? 173
invention might be a relatively trivial task.51 Determining the novelty of an
invention directed at more complex subject matter, however, proves an
increasingly difficult endeavor.52 For example, consider the interesting
case of Titanium Metals Corp. v. Banner.53 In Titanium Metals Corp., the
patent at issue was directed at a titanium-nickel-molybdenum alloy that
resisted corrosion in hot brine environments.54 The patent recited three
claims for a base titanium-nickel-molybdenum alloy consisting of 0.2
percent to 0.4 percent molybdenum and 0.6 percent to 0.9 percent nickel
that could also contain iron.55
The relevant prior art reference asserted against the patent to defeat its
novelty was a highly technical three-page Russian article in the Russian
language.56 The article displayed graphical data generated by various
titanium-nickel-molybdenum alloys, including one alloy having 0.25
percent molybdenum and 0.75 percent nickel by weight.57 Although the
Russian article did not disclose resistance to corrosion in hot brine
environments, the court held that the Russian article anticipated Claims 1
and 2 because the alloy was not new; the Russian alloy clearly fell within
the recited ranges of the claimed invention.58

exclude others from making, using, selling, offering to sell, and importing inventive
technology. See id. at 218.
51. See Seymore, supra note 38, at 923–25 (posing the example of a paper clip made
from an alloy of titanium and nickel; thus, an anticipating prior art reference must disclose a
paper clip made from titanium and nickel).
52. See id. For example, consider a patent directed at the chemical and biological arts
that discloses a specific drug X. Patents directed at drug molecules are typically broad in
scope, even though they disclose specific molecular structures, because the claims are
drafted in such a manner as to ensnare every compound using the basic molecular backbone
of the patented molecule. For example, U.S. Patent No. 5,422,351 is directed at “Bis-benzo
or benzopyrido cyclohepta piperidene, piperidylidene and piperazine compounds” and their
pharmaceutically acceptable salts having a particular structural formula, the claims of which
encompass at least one novemdecillion (1060, or one followed by sixty zeroes) separate
compounds. See Sean B. Seymore, The Presumption of Patentability, 97 MINN. L. REV. 990,
1028 n.225 (2012); see also U.S. Patent No. 5,422,351 (filed June 21, 1991).
53. 778 F.2d 775 (Fed. Cir. 1985).
54. See id. at 776.
55. See id. The claims at issue recited:
1. A titanium base alloy consisting essentially by weight of about 0.6% to 0.9%
nickel, 0.2% to 0.4% molybdenum, up to 0.2% maximum iron, balance titanium,
said alloy being characterized by good corrosion resistance in hot brine
environments.
2. A titanium base alloy as set forth in Claim 1 having up to 0.1% iron, balance
titanium.
3. A titanium base alloy as set forth in Claim 1 having 0.8% nickel, 0.3%
molybdenum, up to 0.1% maximum iron, balance titanium.
Id.
56. See id.
57. See id. at 776–77. This composition clearly falls within the claimed percentages
recited within claims 1 and 2 of the patent.
58. See id. at 782 (“[C]laims 1 and 2 . . . properly construed . . . are anticipated under
§ 102 by the Russian article which admittedly discloses an alloy on which these claims
read.”).
174 FORDHAM LAW REVIEW [Vol. 82
Biotechnology inventions59 pose their own special problems when it
comes to anticipation.60 Notwithstanding the fact that laws of nature,
physical phenomena, and abstract ideas are not patentable,61 a patentee
must differentiate the claimed invention from any previously existing,
naturally occurring compounds to satisfy the novelty requirement.62 This
can be a daunting challenge, as much of life science research involves “the
elucidation of biological mechanisms already long present in nature.”63 A
patentee can successfully differentiate his invention from a naturally
occurring compound by isolating the compound in its purified form.64 This
challenge is especially difficult when the invention concerns metabolites.65
For example, secondary metabolites, which are derived from primary
metabolites, tend to be biologically synthesized in specialized cell types and
at distinct developmental stages, limiting their existence in time and
quantity.66
A patentee that manages to extract, purify, and isolate a useful metabolite
also faces a potential inherency problem.67 The nature of biological
research typically proceeds with some observable experimental finding only
to be understood long after the discovery, if at all.68 Thus, publication of an

59. This term refers to inventions in the biological, chemical and pharmaceutical arts.
60. See Paul G. Alloway, Inherently Difficult Analysis for Inherent and Accidental
Biotechnology Inventions, 38 SUFFOLK U. L. REV. 73, 75 (2004) (“One problem with
biotechnology inventions is that they often relate to discoveries of already-existing natural
biological compositions or mechanisms.”).
61. See 35 U.S.C. § 101 (2006) (describing the statutory requirements for patentable
subject matter). Section 101 states, “Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title.” Id. The Supreme Court held that section 101 is not so broad as to
encompass naturally occurring biological or chemical products. See Diamond v.
Chakrabarty, 447 U.S. 303, 309 (1980).
62. See Alloway, supra note 60, at 75 (noting that inherency is “particularly
problematic” for biotechnology inventions because they often relate to discoveries of
already-existing natural biological compositions or mechanisms).
63. Jeffery M. Duncan, The Court Is Listening, LEGAL TIMES, Nov. 4, 2002, at 2.
64. See In re Bergstrom, 427 F.2d 1394, 1401–02 (C.C.P.A. 1970) (“[B]y definition,
pure materials necessarily differ from less pure or impure materials and, if the latter are the
only ones existing and available as a standard of reference . . . perforce the ‘pure’ materials
are ‘new’ with respect to them.”).
65. See Manuel F. Balandrin et al., Natural Plant Chemicals: Sources of Industrial and
Medicinal Materials, 228 SCIENCE 1154, 1154 (1985) (noting the problems in extracting,
isolating, and purifying primary and secondary metabolites); Gregory S. Walker et al.,
Validation of Isolated Metabolites from Drug Metabolism Studies As Analytical Standards
by Quantitative NMR, 39 DRUG METABOLISM & DISPOSITION 433, 433 (2011) (stating that
many metabolites are difficult and expensive to synthesize chemically).
66. See Balandrin, supra note 65, at 1154 (explaining that secondary metabolites are
frequently accumulated by organisms in smaller quantities than primary metabolites).
67. See Alloway, supra note 60, at 75 (“Inherency is particularly problematic for modern
biotechnology inventions. . . . [This is because] they often relate to discoveries of already-
existing natural biological compositions.”).
68. See id. at 76 (“A second problem that biotechnology inventions often encounter is
that particular observed biological results and underlying mechanisms of biological action
are often not understood until well after publication of initial experimental findings.”).